Validation of two automatic sphygmomanometers according to the modified International Standardization Organization 81060-2:2018 protocol in adults with a mid-upper arm circumference of 22 centimeters or less.

IF 1.2 4区医学 Q4 PERIPHERAL VASCULAR DISEASE Blood Pressure Monitoring Pub Date : 2024-07-02 DOI:10.1097/MBP.0000000000000715

Igor N Posokhov, Evgeny A Praskurnichiy, Olga S Orlova, Ekaterina A Sukhodolova, Aleksandra V Lystseva

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Abstract

Objective: A recent International Organization for Standardization (ISO) Task Group report calls for research to investingate potential special populations in validation studies of automated blood pressure (BP) devices. Accordingly, we aimed to determine the accuracy of two previously validated BP monitors passed in a general population when measured in adults with a mid-upper arm circumference (MUAC) ≤ 22 cm.

Methods: Test device A was the OMRON HEM 7121 equipped with the HEM CS24 cuff designed for an arm circumference of 17-22 cm. Test device B was the YuWell YE660Е with the YuWell '360°' cuff (18-36 cm). Data from 37 participants aged 20.14 ± 2.23 (18-28) years were analyzed according to criterion 1 of ISO Standard 81060-2 : 2018.

Results: According to criterion 1, the mean ± SD of the BP differences for the device A was -7.81 ± 5.20/-10.66 ± 5.48 mmHg (systolic/diastolic) and for the device B was -8.00 ± 6.30/-16.11 ± 5.15 mmHg (systolic/diastolic), respectively. This means that neither device met the requirements.

Conclusion: Since devices A and B, which had passed in a general population study, failed in adults aged 18-28 years with an MUAC ≤ 22 cm, such individuals might be considered as new special population for validation studies.

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根据国际标准化组织修订的 81060-2:2018 协议，对中上臂周长为 22 厘米或以下的成年人使用的两台自动血压计进行验证。

目的：国际标准化组织（ISO）工作组最近的一份报告呼吁在自动血压（BP）设备的验证研究中对潜在的特殊人群进行调查研究。因此，我们旨在确定两款先前通过验证的普通人群血压计在测量中上臂围（MUAC）≤ 22 厘米的成年人时的准确性：测试设备 A 是欧姆龙 HEM 7121，配备 HEM CS24 袖带，专为 17-22 厘米臂围设计。测试设备 B 是配备 YuWell '360°' 袖带（18-36 厘米）的 YuWell YE660Е。根据 ISO 标准 81060-2 : 2018 的标准 1，对 37 名年龄为 20.14 ± 2.23 (18-28) 岁的参与者的数据进行了分析：根据标准 1，设备 A 的血压差异平均值（±SD）分别为-7.81±5.20/-10.66±5.48 mmHg（收缩压/舒张压），设备 B 的血压差异平均值（±SD）分别为-8.00±6.30/-16.11±5.15 mmHg（收缩压/舒张压）。这意味着这两种设备都不符合要求：由于在普通人群研究中合格的装置 A 和装置 B 在 MUAC ≤ 22 厘米的 18-28 岁成人中却不合格，因此可将这些人视为新的特殊人群进行验证研究。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Blood Pressure Monitoring 医学-外周血管病

CiteScore

2.00

自引率

7.70%

发文量

110

审稿时长

>12 weeks

期刊介绍： Blood Pressure Monitoring is devoted to original research in blood pressure measurement and blood pressure variability. It includes device technology, analytical methodology of blood pressure over time and its variability, clinical trials - including, but not limited to, pharmacology - involving blood pressure monitoring, blood pressure reactivity, patient evaluation, and outcomes and effectiveness research. This innovative journal contains papers dealing with all aspects of manual, automated, and ambulatory monitoring. Basic and clinical science papers are considered although the emphasis is on clinical medicine. Submitted articles undergo a preliminary review by the editor. Some articles may be returned to authors without further consideration. Those being considered for publication will undergo further assessment and peer-review by the editors and those invited to do so from a reviewer pool.